1. Field of the Invention
The present invention relates to a saliva sampling and testing device and more particularly to a saliva sampling and testing device which not only allows a technician to collect a sample of saliva without touching the sample, but which also permits either immediate testing or transporting the collected sample of saliva to a clinical laboratory for processing and analyzing.
2. Description of the Prior Art
The current literature indicates saliva is used to conveniently, easily, safely and effectively test an individual for a variety of medical conditions. These tests for medical conditions include hepatitis screening for restaurant employees, HIV (AIDS), continue (nicotine) and cocaine screening by insurance companies and five minute HIV (AIDS) screening by dentist. Clinics for oncology, neurology, infertility, alergy orthopedic and pain which had used urine, blood and serum samples to determine the medical condition of their patients are now using sample of saliva for this same purpose.
U.S. Pat. No. 4,768,238, entitled Bifurcated Saliva Collector, issued to Israel Kleinberg and Leo M. Sreebny, on Sep. 6, 1988, teaches a bifurcated vessel for the collection of saliva. Other relevant patents include U.S. Pat. No. 4,042,337, U.S. Pat. No. 4,589,548, U.S. Pat. No. 4,580,577, U.S. Pat. No. 4,503,572, U.S. Pat. No. 3,871,230, U.S. Pat. No. 3,831,230, U.S. Pat. No. 4,589,548, U.S. Pat. No. 4,283,498 and U.S. Pat. No. 3,518,164. Navazesh and Ship have reviewed the collection of saliva in the American Journal of Otolaryngology, Volume 4, page 288 in 1983.
U.S. Pat. No. 4,635,488, entitled Nonintrusive Body Fluid Samplers and Methods of Using Same, issued to Richard D. Kremer on Jan. 13, 1987, teaches a body fluid sampling device which includes a hollow tube with a solid, porous, water-wettable nonfibrous nib mounted in and protrudes from one end of the tube for collecting, by absorption, a sample of a body fluid such as sweat, tears, or saliva. The sample may be extracted from the nib for analysis by supplying an extraction fluid to the interior of the tube for gravity or vacuum-assisted flow out through the nib. Alternatively, an elongated analysis element such as a strip of paper or a packed column, e.g. containing an agent that changes appearance to indicate the presence of a substance to be detected, may be disposed in the tube for endwise contact with the nib to receive the sample or components thereof by absorption.
U.S. Pat. No. 4,418,702, entitled Method and Apparatus for Collecting Saliva, issued to Paul Brown and Joseph O'Brien on Dec. 6, 1983, and U.S. Pat. No. 4,580,577, entitled Method and Apparatus for Collecting Saliva, issued to Paul Brown and Joseph O'Brien on Apr. 8, 1988, teach a method for collecting saliva from a test subject which includes providing a flavored absorbent mass, such as a sponge, for mastication and charging with saliva and then expressing the saliva from the mass. The apparatus for this method includes a barrel-piston arrangement in association with a specimen vial for storage until diagnostic testing.
U.S. Pat. No. 4,817,632, entitled Oral Fluid Collection Article, issued to Willfried Schramm on Apr. 4, 1989, teaches an oral fluid collection article for placement in the buccal cavity of an individual for the collection and filtering of a saliva fluid. The collection article has a semi-permable membrane container enclosing an osmotic membrane.
U.S. Pat. No. 4,834,110, entitled Suction Clamped Treatment Cup Saliva Sampler, issued to Patricia A. Richard on May 30, 1989, teaches a selective collector of a human patient's saliva for monitoring or analysis is formed as a substantially conical flat concave cup of resilient molded polymer with tubing connections at an apex portal, and a large entrance portal having a soft compliant foam elastomer rim positioned for contact with the patient's soft tissue, such as the interior of the patient's cheek around the parotid salivary duct. Suction is connected to the soft foam rim, holding the concave cup in position, and suction, fixed pressure, pulsing pressure or electrical stimulation may promote the flow of saliva to a collector vessel.
U.S. Pat. No. 4,607,009, entitled Lewis Blood Group Phenotype Assay, issued on Aug. 19, 1986, teaches an assay for determining the Lewis blood group of a patient which consists of testing a body sample for the presence of Lewis antigens. Monoclonal antibodies specific for either of these antigens are employed which do not cross-react with other related antigens. Body samples which may be tested include saliva, serum, urine, and samples of paraffin-embedded tissue. Hybridoma cell lines and the antibody compositions they produce specific for these antigens are provided for use in the assay.
U.S. Pat. No. 4,720,455, entitled Progesterone Assay Method for Mammals and Monoclonal Antibody Therefor, issued to Uma M. Babu, Abdus S. Mia and Gregory D. Pancari on Jan. 19, 1988, teaches a progesterone concentration level test for mammalian body fluids particularly adapted for milk whereby estrus and pregnancy can be determined. The test can be carried out with a kit of several reagents, test tubes and a dip-stick carrying an anti-progesterone monoclonal antibody.
U.S. Pat. No. 4,722,889, entitled Immunoassays Using Multiple Monoclonal Antibodies and Scavenger Antibodies, issued to Jin P. Lee, F. Salcedo and Martin F. Robins On Feb. 2, 1988, teaches a reagent kit is provided for assay of a selected antigen in an aliquot of body fluid. U.S. Pat. No. 4,452,903, entitled Assay Method and Reagent Kit Means for Lipid-containing Body Fluid, issued to Jin P. Lee and Ching Yion Jun. 5, 1984, teaches a reagent kit which is provided for assay of a selected hapten in an aliquot of body fluid containing lipid.
U.S. Pat. No. 4,769,216, entitled Device for Detecting Antigens and Antibodies, issued to Howard M. Chandler, Kevin Healey and John G. Hurrell on Sep. 6, 1988, teaches a device for use in detecting or determining the presence of antigenic or haptenic substances or antibodies in a sample which includes a plurality of tubular or capillary elements, each having antibodies or antigenic or haptenic substances attached to an internal surface thereof, and mechanism for causing fluids to pass simultaneously or sequentially through the plurality of capillary elements. A method and test kit for detecting and determining the presence of antigenic or haptenic substances or antibodies in a sample by the enzyme-linked immunosorbent assay technique is characterized by use of urease as the enzyme in an antibody-enzyme or antigen-enzyme conjugate, with urea being used as the enzyme substrate.
U.S. Pat. No. 4,857,456, entitled Assay of Bone Morphogenetic Protein (BMP) and Anti-BMP Antibody for the Diagnosis of Bone Disorders, issued to Marshall R. Urist on Aug. 15, 1989, teaches a diagnostic kit and a method for diagnosing bone disorders which includes assaying bone morphogenetic protein or anti-bone morphogenetic protein antibody in body fluids. The diagnosis may be carried out by comparing either the bone morphogenetic protein and the anti-bone morphogenetic protein antibody or the ratio of the two to normal assay standards.
U.S. Pat. No. 4,771,486, entitled Sputum Specimen Collecting Device, issued to Charles N. Gutierrez and David Vigil on Sep. 20, 1988, teaches a sputum sampling device having capability for sputum-saliva separation which includes a substantially circular cup having a wall portion which tapers inwardly from top to bottom, a separation plate having a substantially elliptical planar configuration, the major and minor axis of the plate being dimensioned to allow insertion of the plate down into the cup at a slant to position the lower portion of the plate a distance above the bottom of the cup, a plurality of apertures formed in the lower portion of the plate to provide saliva drainage ports, and an upper portion of the plate comprising a roughened textured surface for retracting and holding sputum in position for recovery in order to obtain a sensory and microbiological examination.
U.S. Pat. No. 4,853,325, entitled Saliva Test for Feline Leukemia Virus, issued to Morton A. Vodian, Eric S. Bean and Eric D. LeMoine on Aug. 1, 1989, teaches a saliva test for feline leukemia virus (FeLV) which employs a probe having an immunochemically sensitive member for collecting saliva from the oral cavity of a cat and which employs ELISA reagents for the incubation of the probe and the development of color reactions to indicate the presence or absence of FeLV within the saliva sample collected onto the probe.
U.S. Pat. No. 4,468,470, entitled Method and a Kit for the Assay of Antibodies to Soluble Antigens, issued to Robertus C. Aalberse on Aug. 28, 1984, teaches a method for the assay of antibodies to soluble antigens in an aqueous sample, in particular in body fluids, such as blood serum or blood plasma. The sample is contacted with an antigen in vitro so that antibodies, if present, are bound by the antigens.
U.S. Pat. No. 4,929,544, entitled Reagents, Methods, and Test Kit for Diagnosing/monitoring Cancer in Humans, issued to Barbara S. Vold on May 29, 1990, teaches that a quantitative immunoassay is used to diagnose/monitor human cancer by measuring a physiological fluid specimen of a subject. The quantitative immunoassay employs a monoclonal antibody and either compares that level to the level which occurs in corresponding physiological fluid of normal subjects to determine whether the former is substantially elevated over the latter or compares that level to the level of present in specimens taken from the subject at different times.
U.S. Pat. No. 4,942,122, entitled AIDS Prognosis Test Detecting the Presence of Antibodies Inhibiting HIV Reverse Transcriptase, issued to David T. Imagawa, Moon H. Lee and Kouichi Sano on Jul. 17, 1990, teaches a kit detects the presence of an antibody inhibiting HIV reverse transcriptase. The amount of antibody inhibiting HIV reverse transcriptase present in the body fluids of a patient known to be immunopositive for HIV gives the clinician a means to form a prognosis for each individual case.
U.S. Pat. No. 4,447,528, entitled Detecting Intrinsic Factor Blocking Site Antibody, issued to James E. Ellis, Graham P. Lidgard, Gerald Odstrchel and Louis J. Riceberg on May 8, 1984, teaches a radioassay reagent kit therefor which is for detecting auto blocking antibody, such as auto blocking antibody which interferes with the complexation of intrinsic factor with a vitamin. A receptor, i.e., intrinsic factor, is immobilized on a support and the amount of ligand, i.e., vitamin, capable of binding therewith in the presence of a biological fluid sample is determined.
U.S. Pat. No. 4,865,966, entitled Method for Detecting Antibodies to Human Immunodeficiency Virus, issued to Alvin E. Friedman-Kien and Yunzhen Cao on Sep. 12, 1989, teaches in a method of screening mammals for antibodies to viral agents a urine sample is collected from a mammal to be tested. The urine sample is assayed the sample for antibodies directed against the specific viral agent.